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NCT05761561
Trial of Exercise and Lifestyle in Women With Ovarian Cancer
Conditions: Ovarian Cancer
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Yale University
Location: United States
Summary
An anticipated 200 women with newly diagnosed ovarian cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami.Participants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm.Study assessments will be conducted at baseline, post-chemotherapy/end of intervention and at 1-year post diagnosis.
Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery.Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.
Eligibility Criteria
Inclusion Criteria:have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IVbe scheduled to receive neoadjuvant or adjuvant chemotherapybe physically able to walk without a walking aid (e.g.
cane or walker)be able to complete forms, understand instructions and read intervention book in English or Spanishagree to be randomly assigned to either grouphave clearance from oncologist to participatebe ≥ 18 years of ageExclusion Criteria:having already completed a 2nd cycle of chemotherapyalready practicing dietary physical activity guidelines (≥150 min per week of moderate to vigorous exercise) in the 6 months prior to diagnosispregnancy or intention to become pregnantrecent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction <40%presence of dementia or major psychiatric diseasein active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments)
Source: ClinicalTrials.gov (NCT05761561). StuddyBuddy aggregates publicly available trial information.